Immuno-oncology

Over 140 biopharma leaders share their views on developments to watch for in key therapeutic areas this year. Advances in multiple scientific fields are opening up new avenues for treatment.

Novartis president, development and chief medical officer talks about the pivotal role of the development India hub in progressing breakthrough drugs, how AI is delivering gains in the trials arena, driving focus in the R&D engine and the Swiss group’s approach in the obesity space.

The checkpoint inhibitor combo missed a recurrence-free survival endpoint in Phase III in post-surgical melanoma. The LAG-3 inhibitor-containing product continues development in lung cancer, however.

Scrip surveys some of the more interesting Phase III clinical trial readouts expected this year.

Oncology-focused venture eyes potential US approval for first-line use as it kicks off expanded development of light-activated therapy.

The potentially groundbreaking approach would use immunotherapy or targeted therapies against pre-cancerous cells to prevent cancer from developing at all.

The company presented promising Phase II data at the ASCO-GI conference for evorpacept, a drug whose target has been problematic for other drug makers.

The Danish drugmaker, best known for dermatology, has secured the European rights to Shanghai Junshi Biosciences’ cancer therapy toripalimab, which was the first Chinese PD-1/L1 checkpoint inhibitor to be approved in the US.

The FDA green light for Datroway in breast cancer marks the first for a TROP2-directed antibody-drug conjugate and is a relief for partners AstraZeneca and Daiichi Sankyo after multiple filing mis-steps in its lung cancer indication.

The drug maker announced positive topline Phase III results for its subcutaneous PD-1 inhibitor sasanlimab in first-line, BCG-naïve non-muscle invasive bladder cancer combined with BCG.

Five months after taking over the dual-masked T-cell engagers from Sanofi amid a restructuring, the company posted promising initial Phase I data from its PSMA- and HER2-targeting IO candidates.

Galapagos and Gilead are calling time on their ill-fated licensing deal and the Belgian biotech is looking to unlock value by creating a business development-focused spin-out armed with a €2.45bn cash pile. Major job cuts are also on the cards.

Topline Phase III results in EGFR exon 19 deletion/L858R substitution mutation NSCLC indicate more than a year in overall survival improvement over Tagrisso, the current standard of care.

While quieter than some recent years, 2024 did produce several clinical trial readouts destined to have an impact on their respective markets. Here, in roughly chronological order, Scrip takes a look at the 10 clinical stories that got readers clicking the most over the past 12 months.

The new year has already brought multiple deals for China-originated antibody-drug conjugates in the DLL3 class, which companies in the country dominate.

The partners have decided to voluntarily withdraw their EU marketing application for datopotamab deruxtecan in lung cancer, based on regulator feedback, a month after a similar move in the US.

CytoCares’ CEO shares plans for CC312, a potentially first-in-class trispecific antibody for autoimmune disorders it sees as differentiated from global rivals.

After investing heavily in both mechanisms for IO-IO combinations, Merck is cutting its losses with vibostolimab and favezelimab, and switching its anticancer bets to other modalities.

Expert panelists discuss regulatory challenges, flexible approaches to assay selection, and applying scientific reasoning with guidelines to address immunogenicity and safety assessment challenges in oncology biologics and biosimilars.

The biotech’s lead candidate now looks approvable as the first new localized prostate cancer treatment in 20 years – allowing Candel to raise much-needed funds – but a filing must wait